Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

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Lower Court Agrees With WuXi AppTec (And Many Of Us)

A lower-court ruling does not make a victory. But it adds a little sanity to this melodrama. On August 7, a U.S. District Judge did something that has been surprisingly rare in the long-running WuXi AppTec/BIOSECURE Act saga: He looked at the U.S. government's case for labeling WuXi a “Chinese military company” and decided the government had not shown enough evidence. Analysis from Chief Editor Louis Garguilo.

GUEST COLUMNISTS

Are Biopharma Companies Outsourcing Their Ability To Think?
Amid gaining immediate access to external manufacturing capabilities, sponsor companies can lose the foundational understanding required to govern that capability.
June 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
The Decision Rights Matrix: Making Sponsor-CDMO Governance Enforceable
In LVV manufacturing, the quality target product profile and the DRM are designed to work together. One defines what is being governed, the other names who governs it.
Defining Quality In A Sponsor-Owned QTPP Before The CDMO Even Starts
Version-controlled quality target product profiles, authored by the drug sponsor, close any gaps between the CDMO's and sponsor's definitions of quality.
Reshoring Pressure Meets Manufacturing Reality
U.S. pharma can't reshore what domestic capacity can't absorb. Senior leaders from Takeda, Biogen, Eli Lilly, and others reveal why tariff pressure is colliding with a sterile fill-finish shortage, workforce gaps, and ADC capacity bottlenecks.
CDMO Live Europe 2026: Partnerships For An Uncertain World
112 pages of executive insight from CDMO Live Europe 2026: tariffs, geopolitics, supply resilience, AI in manufacturing, and why strategic partnerships remain aspirational for most.
Resilience, Risk, And Relationships: CDMO Live Europe 2026 Report
Senior pharma leaders from Pfizer, Bayer, BioNTech and others debunk dual sourcing myths and reveal what separates strategic CDMO partnerships from transactional ones.
Demonstrating Non-Inferiority Of BFPCs Vs. Traditional Air Monitoring
Demonstrating non-inferiority of bio-fluorescent particle counter (BFPC) technology to traditional active air-sampling methods is essential for implementation. Here's how to approach it.

PHARMA OUTSOURCING WHITE PAPERS

ADC Manufacturing: Practices, Challenges, And The Road Ahead
ADCs are advancing quickly, but manufacturing complexity is rising just as fast. Key challenges in scale-up, regulation, and costs are reshaping how the next generation of therapies will be delivered.

Bridging Studies For Producer Cell Line Adoption: Regulatory And Development Perspectives
Explore how analytical comparability, risk assessment, and bridging strategies can support a smooth and compliant platform transition.
Phase-Appropriate Approaches To Manufacturing And Testing
Accelerate the development of high-quality biopharmaceuticals by implementing phase-appropriate, risk-based manufacturing and testing strategies that ensure timely progression.
Harnessing Chemistry For Scalable Manufacture Of Lipids Used In mRNA Delivery
Discover how scalable lipid nanoparticle (LNP) technology is revolutionizing mRNA-based therapies and shaping the future of treatment innovation.
Redefining Value In Biologics Outsourcing Partnerships
Biologics outsourcing is shifting to strategic partnerships focused on modality expertise, regulatory excellence, and integrated end-to-end capabilities.
FDA's Regenerative Medicine Advanced Therapy (RMAT) Program
RMAT qualification requires preliminary clinical evidence demonstrating the potential to address an unmet medical need. This designation grants benefits like intensive guidance and faster FDA review.